A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006)

Allergan

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Rescue medication; Drug: Placebo-matching MK-1602; Drug: MK-1602

Study type: Interventional

Funder types: Industry

Identifiers

NCT01613248

1602-006

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness, safety and tolerability of a range of doses of MK-1602 versus placebo in the treatment of acute migraine.

Enrollment: 834 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > 1 year history of migraine with or without aura as defined by International Headache Society (IHS) criteria 1.1 and/or 1.2
• Migraines typically last between 4 to 72 hours, if untreated
• ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of

the two months prior to screening

• Male, female who is not of reproductive potential, or female of

reproductive potential with a screening serum β-human chorionic gonadotropin (β-hCG) level consistent with a not-pregnant state, and who agrees to use acceptable contraception

Exclusion criteria

• Pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation
• Participant has difficulty distinguishing his/her migraine attacks from tension-type headaches
• History of predominantly mild migraine attacks or migraines that usually

resolve spontaneously in less than two hours

• More than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the three months prior to screening
• Basilar-type or hemiplegic migraine headache
• > 50 years old at age of migraine onset
• Taking migraine prophylactic medication where the prescribed daily dose

has changed during the 3 months prior to screening and will not be changed

during the study

• Taking a proton pump inhibitor (PPI) or a histamine receptor 2 (H2) blocker on a daily or near daily basis (> 3 days per week)
• Taking the following medications from 1 month prior to screening through study period: potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., cyclosporine, itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone, telithromycin, cimetidine, quinine, diltiazem, verapamil, and human immunodeficiency virus [HIV] protease inhibitors), moderate or marked CYP3A4 inducers (e.g., rifampicin, rifabutin, barbiturates [e.g., phenobarbital and primidone], systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, and St. Johns wort), or drugs with narrow therapeutic margins and potential for drug interactions in the CYP2C family (e.g., warfarin)
• Participant is unable to refrain from consumption of grapefruit or grapefruit juice during study
• History of hypersensitivity to, or has experienced a serious adverse event

in response to 3 or more classes of drugs (prescription and over-the-counter)

• Clinical or laboratory evidence of uncontrolled diabetes, human immunodeficiency virus (HIV) disease, or significant pulmonary, renal, hepatic, endocrine, or other systemic disease
• Other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, dementia or significant neurological disorders other than migraine. Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled are eligible to participate
• Participant is at imminent risk of self-harm
• History of malignancy ≤ 5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
• History of gastric or small intestinal surgery (including gastric bypass

surgery or banding), or presence of a disease that causes malabsorption

• Participant has recent history (within the last year) of drug or alcohol abuse or dependence or is a user of recreational or illicit drugs
• Participant is legally or mentally incapacitated
• Donation of blood products or phlebotomy of > 300 ml within 8

weeks of study, or intent to donate blood products or receive

blood products within 30 days of screening and throughout study

• Intent to donate eggs or sperm within the projected duration of the

study

• Current participation in or participation within 30 days of screening

in a study with an investigational compound or device

• Previous exposure to MK-0974 and/or MK-3207
• Use within the past 2 months of an opioid- or barbiturate-containing

analgesic for migraine relief

• Inpatient or emergency department treatment of an acute migraine

attack within the past 2 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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834 participants in 6 patient groups, including a placebo group

MK-1602 1 mg

Experimental group

Description:

MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: MK-1602

MK-1602 10 mg

Experimental group

Description:

MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: MK-1602

MK-1602 25 mg

Experimental group

Description:

MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: MK-1602

MK-1602 50 mg

Experimental group

Description:

MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: MK-1602

MK-1602 100 mg

Experimental group

Description:

MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: MK-1602

Placebo

Placebo Comparator group

Description:

Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.

Treatment:

Drug: Rescue medication

Drug: Placebo-matching MK-1602